Celcuity Inc. (CELC) recently reported new clinical and regulatory progress for Gedatolisib, its PI3K/mTOR inhibitor being evaluated across multiple late-stage programs for HR-positive, HER2-negative advanced breast cancer.
Data from the VIKTORIA-1 Phase 3 trial showed that Gedatolisib combination regimens doubled the likelihood of patients remaining alive without disease progression or death compared to alpelisib plus fulvestrant in PIK3CA-mutant cohort. In this cohort, the Gedatolisib triplet regimen with fulvestrant and palbociclib achieved a median progression-free survival of 11.1 months, while Gedatolisib doublet regimen with fulvestrant achieved 11.3 months, compared to 5.6 months for the control arm. The company noted that both Gedatolisib regimens demonstrated favorable tolerability profiles with lower rates of high-grade adverse events and fewer treatment discontinuations than the comparator regimen.
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